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It is also argued that extending intellectual property rights actually creates barriers to trade. See Mitchell, A. D. and Voon, T., “TRIPS,” in: Bethlehem, D. Van Damme, I. Neufeld, R., and McRae, D., eds., The Oxford Handbook on International Trade Law (Oxford: Oxford University Press, 2009): 186–208, at 187 et seq; and Lindstrom, B., “Scaling Back TRIPS-Plus: An Analysis of Intellectual Property Provisions in Trade Agreements and Implications for Asia and the Pacific,” NYU Journal of International Law and Politics 42, no. 3 (2010): 917–980, at 921.Google Scholar

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Evergreening refers to the variety of strategies employed by patent holders to prolong monopolies by securing additional patent protection for minor and arguably trivial product variations, thereby delaying generic competition, and facilitating maintenance of monopoly pricing.Google Scholar

Despite referring specifically to delay in the “marketing approval process,” this is generally interpreted as the delay between the granting of the patent and the entry to market, rather than within the regulatory evaluation process per se. Delays in generic market entry are usually taken to refer to the period of time between the discovery and patenting of the molecular entity and its entry to market, which because of the long lead times required for clinical trials can be 10–15 years. However, in reality the marketing approval process only begins with the submission of an application dossier to the regulatory agency.Google Scholar

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See Sell, , supra note 3, at 62. Patent linkage mechanism fundamentally alter the role and remit of the regulatory agency, forcing them to take into account factors not relevant to the safety, efficacy or quality of the product for which marketing approval is being sought, and requiring them to adjudicate the existence and/or relevance of patents on reference products.Google Scholar

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In some jurisdictions, it is possible for a generic manufacturer to submit a literature-based application, relying on efficacy and safety data already in the public domain rather than on the dossier submitted by the originator. A literature-based submission is not possible unless protection is limited to undisclosed data. This distinguishes a data “protection” from a data “exclusivity” regime.Google Scholar

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